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New hope for high-risk research?
Newsdesk Studies reveal new HRT dangers
648
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
Combined HRT is associated with long-term risks.
Analysis of bone density and fractures showed a 24% reduction in
fractures and a 3·7% increase in bone density in women receiving combined HRT. However, the researchers concluded that the treatment should not be administered to prevent osteoporosis in patients without menopausal symptoms. “The results themselves have clearly shifted our thinking about the proper use of hormone therapy in women”, comments Anderson. “It is no longer acceptable to assume that women entering menopause should automatically be given hormone therapy.”
© Sheila Terry/Science Photo Library
Two new studies into the side-effects of combined hormone-replacement therapy (HRT) confirm dangers associated with long-term use, according to the Women’s Health Initiative (WHI) who reported their findings in JAMA (2003; 290: 1729–38; 1739–48). The researchers concluded that there was an increased incidence of ovarian cancer and a slight decrease in endometrial cancer, in patients taking HRT. However, women receiving an oestrogen and progesterone combination had a higher bone density by the end of the trial and suffered fewer bone fractures. The WHI’s double-blind, placebocontrolled, randomised trial enrolled 16 608 postmenopausal women in the USA between September 1993 and October 1998, and aimed to investigate possible associations of HRT with several disorders. The study was stopped earlier than planned because the risks of the therapy were considered too dangerous to justify the benefits. Previous publications from this large trial have linked HRT use with an increased risk of dementia, stroke, coronary heart disease, and breast cancer. The last of these findings was confirmed by the Million Women Study, published in The Lancet this summer (2003; 362: 419–27). Garnet Anderson, Fred Hutchinson Cancer Research Centre, WA, USA, led the study into associations of combined HRT and gynaecological cancers. Anderson emphasised that ovarian cancer is rare, and the limited findings require further investigation. “I hope that better powered, carefully conducted observational studies will provide our estimates of the association between continuous combined hormones and ovarian cancer”, he says. One positive result from this study is that use of combined HRT does not increase endometrial cancer. However, Anderson warns of another possible implication of using the combined therapy. “A non-trivial proportion of women experienced bleeding”, he explains, “this cannot be dismissed as simply a benign consequence of the therapy”.
Rachel Liddle
New hope for high-risk research? The recently-launched NIH Roadmap for Medical Research, a series of 28 new initiatives designed to facilitate translational research, may offer new hope for patients enrolled in clinical trials for novel therapies. Investigators who seek support for this type of highrisk research are also likely to benefit. The Roadmap was announced at a press briefing led by NIH Director Elias Zerhouni and a panel of NIH institute directors (Sept 30, 2003; Washington, DC, USA). “This is truly not business as usual for medical research”, Zerhouni told the audience. “All these initiatives are integrated to accelerate and translate our knowledge into effective treatment and prevention strategies, transforming the way we do research, and the translation of that research from the bench to the bedside and into clinical practice.” This could be heartening news for cancer patients who, each year, fail standard treatment regimens and enroll in clinical trials testing novel therapies, the benefits of which may not be realised for many years. “These patients are willing to make themselves available to us, as a research community, which I view as a solemn privilege”, says Ira Mellman, Chairman of the Department of Cell Biology at Yale University, CT, USA. “We should try to learn as much from them as possible, in light of the
contribution they are making.” The risks associated with this type of research relate both to the patients, whose advanced disease lends added concerns regarding protocol safety, and to treatments, which must often go through years of testing in costly trials. “We in academia need to work to establish teams comprised of people who are involved in the basic discovery, identification, optimisation, and production of therapeutic products, and in the conduct of clinical trials. You need to coordinate with a clinical trials infrastructure that is accessible at all levels.” Comments William Crowley, Professor of Medicine at Harvard Medical School and Director of Clinical Research at Massachusetts General Hospital, MA, USA: “Zerhouni’s vision is compelling and shows a deep appreciation of major problems relating to the [translational] bottleneck that basic and clinical scientists increasingly encounter. Without addition to the NIH budget of the US$2·1 billion targeted for these initiatives, the changes might not happen, or worse, they will be done at the expense of ongoing research. It’s important that the [United States’] legislators view these changes as imperative, and act promptly to fund them.” Mary Weideman
THE LANCET Oncology Vol 4 November 2003
http://oncology.thelancet.com
For personal use. Only reproduce with permission from The Lancet.
648
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
Combined HRT is associated with long-term risks.
Analysis of bone density and fractures showed a 24% reduction in
fractures and a 3·7% increase in bone density in women receiving combined HRT. However, the researchers concluded that the treatment should not be administered to prevent osteoporosis in patients without menopausal symptoms. “The results themselves have clearly shifted our thinking about the proper use of hormone therapy in women”, comments Anderson. “It is no longer acceptable to assume that women entering menopause should automatically be given hormone therapy.”
© Sheila Terry/Science Photo Library
Two new studies into the side-effects of combined hormone-replacement therapy (HRT) confirm dangers associated with long-term use, according to the Women’s Health Initiative (WHI) who reported their findings in JAMA (2003; 290: 1729–38; 1739–48). The researchers concluded that there was an increased incidence of ovarian cancer and a slight decrease in endometrial cancer, in patients taking HRT. However, women receiving an oestrogen and progesterone combination had a higher bone density by the end of the trial and suffered fewer bone fractures. The WHI’s double-blind, placebocontrolled, randomised trial enrolled 16 608 postmenopausal women in the USA between September 1993 and October 1998, and aimed to investigate possible associations of HRT with several disorders. The study was stopped earlier than planned because the risks of the therapy were considered too dangerous to justify the benefits. Previous publications from this large trial have linked HRT use with an increased risk of dementia, stroke, coronary heart disease, and breast cancer. The last of these findings was confirmed by the Million Women Study, published in The Lancet this summer (2003; 362: 419–27). Garnet Anderson, Fred Hutchinson Cancer Research Centre, WA, USA, led the study into associations of combined HRT and gynaecological cancers. Anderson emphasised that ovarian cancer is rare, and the limited findings require further investigation. “I hope that better powered, carefully conducted observational studies will provide our estimates of the association between continuous combined hormones and ovarian cancer”, he says. One positive result from this study is that use of combined HRT does not increase endometrial cancer. However, Anderson warns of another possible implication of using the combined therapy. “A non-trivial proportion of women experienced bleeding”, he explains, “this cannot be dismissed as simply a benign consequence of the therapy”.
Rachel Liddle
New hope for high-risk research? The recently-launched NIH Roadmap for Medical Research, a series of 28 new initiatives designed to facilitate translational research, may offer new hope for patients enrolled in clinical trials for novel therapies. Investigators who seek support for this type of highrisk research are also likely to benefit. The Roadmap was announced at a press briefing led by NIH Director Elias Zerhouni and a panel of NIH institute directors (Sept 30, 2003; Washington, DC, USA). “This is truly not business as usual for medical research”, Zerhouni told the audience. “All these initiatives are integrated to accelerate and translate our knowledge into effective treatment and prevention strategies, transforming the way we do research, and the translation of that research from the bench to the bedside and into clinical practice.” This could be heartening news for cancer patients who, each year, fail standard treatment regimens and enroll in clinical trials testing novel therapies, the benefits of which may not be realised for many years. “These patients are willing to make themselves available to us, as a research community, which I view as a solemn privilege”, says Ira Mellman, Chairman of the Department of Cell Biology at Yale University, CT, USA. “We should try to learn as much from them as possible, in light of the
contribution they are making.” The risks associated with this type of research relate both to the patients, whose advanced disease lends added concerns regarding protocol safety, and to treatments, which must often go through years of testing in costly trials. “We in academia need to work to establish teams comprised of people who are involved in the basic discovery, identification, optimisation, and production of therapeutic products, and in the conduct of clinical trials. You need to coordinate with a clinical trials infrastructure that is accessible at all levels.” Comments William Crowley, Professor of Medicine at Harvard Medical School and Director of Clinical Research at Massachusetts General Hospital, MA, USA: “Zerhouni’s vision is compelling and shows a deep appreciation of major problems relating to the [translational] bottleneck that basic and clinical scientists increasingly encounter. Without addition to the NIH budget of the US$2·1 billion targeted for these initiatives, the changes might not happen, or worse, they will be done at the expense of ongoing research. It’s important that the [United States’] legislators view these changes as imperative, and act promptly to fund them.” Mary Weideman
THE LANCET Oncology Vol 4 November 2003
http://oncology.thelancet.com
For personal use. Only reproduce with permission from The Lancet.